Suppliers / Ferndale Laboratories

Ferndale Laboratories

United States 129 employees Updated 9 July 2026

Ferndale Laboratories is a finished-dose manufacturer based in United States. It appears in 19 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA, EMA and MPA (SE). Its GMP standing is certified by US FDA and MHRA (UK). Its most recent recorded inspection, by US FDA, closed on 27 February 2026 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
19
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 27 February 2026 VAI US FDA
  • 4 March 2022 VAI US FDA
  • 3 February 2017 VAI US FDA
  • 24 April 2015 VAI US FDA
  • 14 January 2014 VAI US FDA
  • 13 December 2011 VAI US FDA
  • 7 January 2011 NAI US FDA
  • 18 August 2010 OAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
FERNDALE, United States Not on file
Ferndale, United States 1811212

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 16 1
EMA 2 None
MPA (SE) 1 None
MHRA (UK) None 1

Questions about Ferndale Laboratories

Does Ferndale Laboratories hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Ferndale Laboratories. It does have 19 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Ferndale Laboratories FDA-registered?
One site operated by Ferndale Laboratories carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Ferndale Laboratories's last inspection go?
The most recent inspection on record closed on 27 February 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 1 closed as OAI.
Where does Ferndale Laboratories manufacture?
2 registered sites are on record, in United States (Ferndale and Ferndale). Every site is listed on this page with the register it came from.
Which regulators recognise Ferndale Laboratories's GMP?
Current GMP certificates are on record from US FDA and MHRA (UK). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 27 February 2026.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates